Omega-3-Acid Ethyl Esters

Product NDC
63629-6805
11-digit product format
636296805
Labeler code
63629
Product ID
63629-6805_ceae55b2-57b8-4bc1-ab9a-600a194685c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
omega-3-acid ethyl esters
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA091018
Marketing category
ANDA
Marketing start
2014-06-30
Marketing end
0000-00-00
Substance
OMEGA-3-ACID ETHYL ESTERS
Active strength
900 mg/1
Pharmacologic classes
Fatty Acids, Omega-3 [CS],Omega-3 Fatty Acid [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-6805-16362968050130 CAPSULE, LIQUID FILLED in 1 BOTTLE (63629-6805-1) 2015-09-300000-00-00NoNoCurrent
63629-6805-26362968050290 CAPSULE, LIQUID FILLED in 1 BOTTLE (63629-6805-2) 2015-09-300000-00-00NoNoCurrent